Kornimate/medical-research-clean huggingface dataset:
a feasibility trial of geriatric assessment and management for older cancer patients

Conditions: Breast Cancer; Gastrointestinal Cancer; Genitourinary Cancer

Summary: the purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (geriatric assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy. secondarily, the study will investigate the impact of the geriatric assessment on the cancer treatment decision of the cancer specialist.

introduction: a comprehensive geriatric assessment (cga) can identify functional and psychosocial issues in older cancer patients, which in turn can inform interventions to prevent/postpone adverse outcomes and maintain/improve the functional status and well-being of this population. however, few randomized controlled trials (rcts) have been completed showing the evidence. objective - to explore the feasibility and impact of a cga followed by an integrated care plan on quality of life and functional status for older adults with advanced breast, gastrointestinal or genitourinary cancer methods - a two-group parallel single-blind phase ii rct is enrolling 60 patients aged 70 or above, diagnosed with cancer, and starting first line chemotherapy at princess margaret cancer centre in toronto. the randomization using sealed opaque envelopes is stratified by treatment intent (adjuvant versus palliative). the intervention entails a comprehensive cga by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified. participants in the intervention group are seen at baseline for the cga and for initiation of the integrated care plan, and again at 3 and 6 months to assess intervention fidelity and measure outcomes. the co-primary outcomes are: 1) maintaining/improvement in quality of life; 2) refining of cancer treatment plan. the secondary outcomes include: 1) functional status; 2) feasibility of the study by tumor site. recruitment has been completed november 2015

Eligibility criteria:
inclusion criteria: * clinical diagnosis of advanced (stage 2, 3 or 4) gastrointestinal, genitourinary, or breast cancer * referred for first-line chemotherapy * ability to speak english * physician estimated life expectancy \>6 months * an eastern oncology group collaborative (ecog) performance score of 0-2 * ability to provide informed consent exclusion criteria: * previous chemotherapy for current stage of disease

Keywords: geriatric oncology quality of life comprehensive geriatric assessment functional status chemotherapy older adults
a study of roactemra/actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic dmards

Conditions: Rheumatoid Arthritis

Summary: this multicenter, open-label, single arm study will assess the safety and efficacy of roactemra/actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (dmards). patients will receive roactemra/actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. anticipated time on study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe active rheumatoid arthritis (ra) of \>/= 6 months duration * prior treatment with dmards for \>/= 12 weeks (at stable dose for \>/= 8 weeks) * inadequate clinical response to stable dose of non-biologic dmard (either single or in combination) exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment * autoimmune disease other than ra * history of or current inflammatory joint disease other than ra * previous treatment with any biologic drug that is used in the treatment of ra * intra-articular or parenteral corticosteroids within 6 weeks prior to baseline * impaired liver, renal or hematologic function * active current or history of recurrent infection * history of or currently active primary or secondary immunodeficiency
realtime diagnosis from electrocardiogram artificial intelligence-guided screening for atrial fibrillation with long follow-up (regal)

Conditions: Atrial Fibrillation

Summary: the purpose of this research is to test whether apple watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * had a 10-second 12-lead ecg done at mayo clinic * have a high ai-ecg risk score indicating a high likelihood of previously unrecognized af * men with cha2ds2-vasc2 ≥2 or women with cha2ds2-vasc ≥ 3 exclusion criteria: * diagnosed atrial fibrillation * diagnosed dementia * diagnosed end-stage kidney disease * history of intracranial bleeding * have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder * missing date of birth * residence outside of the u.s. or missing address information
reinnervation and neuromuscular transmission in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the aim of this study is to describe the changes in the neuromuscular connection in patients with amyotrophic lateral sclerosis (als). the study consist of three substudies that have the following main hypothesis: 1. that als patients do not demonstrate equal capacity for muscle reinnervation and that reinnervation preserves muscle function and thereby slows down progression. 2. that blood concentrations of c-terminal agrin fragment (bcaf) reflect neuromuscular transmission deficiency and that blood concentration of neural cell adhesion molecule reflects degree of muscle denervation in patients. 3. that als patients with decrement when examined with repetitive nerve stimulation have more physical fatigue, slower progression, higher degree of reinnervation and higher bcaf compared to als patients without decrement. there will be 3 inclusion groups. 1. patients referred for neurophysiological examination on suspicion of motor neuron disease. 2. healthy controls 3. disease control: patients with another motor neuron disease with slow progression. all participants will be invited for at least 1 visit (baseline). if participants in group 1 eventually receive the diagnosis of als they will be invited for 2 additional visits 4 og 8 months after baseline visit, respectively. examinations will consist of: * nerve conduction study * repetitive nerve stimulation (except for healthy controls) to examine impairment of the neuromuscular connection. * motor unit number estimation with mscanfit to estimate number and size of motor units. * ultrasound examination of muscles to measure size and condition of muscles. * questionnaires on fatigue and functional status. * blood sample for measurement of specialized analysis (c-terminal agrin fragment and neural cell adhesion molecule) and routine analysis (liver and kidney function as well as neurofilament light chain) * muscle strength assessment manually and by dynamometer to follow progression of muscle weakness * bioelectrical impedance measurement to follow the overall body composition.


Eligibility criteria:
inclusion criteria: * referred to clinical neurophysiological examination on suspicion of motor neuron disease or diagnosed with als according to gold coast criteria within the last 3 months. * age ≥18 years old * able and willing to provide informed consent exclusion criteria: * former central or peripheral nervous system disease * diabetes * electrophysiological signs of polyneuropathy at baseline visit * pacemaker * pregnancy for disease controls the exclusion criteria are the same, but the inclusion criteria: * diagnosed with disease with slow, progressive loss of motor neurons * age ≥18 years old * able and willing to provide informed consent
multimodal physician intervention to detect amblyopia

Conditions: Amblyopia; Strabismus

Summary: current research shows low rates of quantitative vision screening at preschool ages in the medical home. this study targets providers (pcps) to evaluate the effectiveness of a web-based intervention to improve knowledge about strabismus, amblyopia and preschool vision screening, to increase preschool vision screening rates, and to improve rates of diagnosis of strabismus and amblyopia by eye specialists.

despite decades of research showing adverse neural consequences of abnormal vision, little has changed for amblyopic children. over the past 40 years, data have shown that most children with amblyopia are detected late. in our health care system, primary care physicians play a pivotal role in translating findings about amblyopia into practice. but, our experience with the maternal and child health bureau (mchb) / nei expert panel on vision screening in the preschool child and the mchb/ american academy of pediatrics (aap) project universal preschool vision screening revealed that primary care physicians get very little training about amblyopia and risk factors. consequently, many do not screen aggressively for these conditions. the university of alabama departments of optometry, pediatrics and continuing medical education, in collaboration medicaid agencies in alabama, south carolina and illinois, have developed a novel, internet-based, multi-modal strategy to increase the understanding and recognition of amblyopia and its risk factors by pediatricians and primary care physicians in office based settings. we have designed a cluster-randomized, controlled clinical trial to test whether our intervention results in improved performance by "intervention" physicians compared to control physicians (exposed to a web-based intervention for pediatric blood pressure screening and adolescent chlamydia screening). our design, along with pre / post-intervention and control / intervention performance measures, will evaluate changes in practice attributable to the intervention versus those occurring from other sources over time. our final analysis will show whether preschool patients of intervention physicians are more likely to be identified with strabismus or amblyopia. this research forges a critical link between the truly phenomenal body of amblyopia research fostered by the nei and the health care offered to american children.

Eligibility criteria:
inclusion criteria: * files medicaid claims for at least 8 well child visits for children aged 3 or 4 years during one year, * files claims under individual name, * has internet access. exclusion criteria: * files fewer than 8 medicaid claims for well child visits for children aged 3 or 4 years old during one year, * files claims under a clinic name, * does not have internet access.

Keywords: preschool screening cluster randomized physician practice patterns behavior knowledge attitudes guideline adherence
study aims to collect information in routine clinical practice in italy about the number of patients suffering from irregularly heart beats which are not caused by a heart valve problem (non-valvular atrial fibrillation, nvaf) who stopped or changed rivaroxaban treatment

Conditions: Non-valvular Atrial Fibrillation

Summary: while it is well known that stopping or changing medication with blood thinners in patients who suffer from non-valvular atrial fibrillation (nvaf) increases the risk of ischemic stroke (a condition which occurs when a vessel supplying blood to the brain is obstructed), bleeding or thromboembolism (a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel), limited data are available on the number of nvaf patients and the reasons why nvaf patients in italy stop or change their treatment with blood thinners to prevent stroke or thromboembolism. by following the nvaf patients in routine clinical practice in italy who are treated with rivaroxaban to prevent stroke or systemic embolism researchers want to find out how many nvaf patients and for what reasons nvaf patients stopped or changed rivaroxaban treatment. study data will be collected through patients' routine visits at their treating doctor over a period of 24 months for each patient.


Eligibility criteria:
inclusion criteria: * age \>= 18 * patient with a diagnosis of nvaf * new user to rivaroxaban, naïve or non naïve to treatment with oral anticoagulant * patient for whom the decision to initiate treatment with rivaroxaban was made as per physician's routine treatment practice for prevention of stroke and non-central nervous system (cns) systemic embolism * signed an informed consent exclusion criteria: * patient with heart valve replacement * patient is participating in an investigational program with interventions outside of routine clinical practice

Keywords: atrial fibrillation (af) nvaf
safety and tolerability of seroguard use

Conditions: Adhesion

Summary: the performed study of safety and tolerability of seroguard, solution (jsc pharmasyntez, russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile

the present study was conducted as multicenter, randomized, double-blind, parallel group clinical study. after successful completion of screening procedures, patient underwent a planned laparoscopy. randomization of patients into groups was performed on the day of surgery using envelops. the test drug or the placebo were used at the completion stage of surgery. monitoring of patient on inpatient basis was performed for 6 days after completion of surgery. discharge of patient from the hospital with no contraindications was possible on day 7 of the study. in this case the follow-up of patient was performed on outpatient basis. follow-up was performed for 4 weeks before day 28 of the study. study procedures aimed at evaluation of safety and tolerability of using the test drug or the placebo were identical in main and control groups.

Eligibility criteria:
inclusion criteria: 1. male and female patients. 2. age from 18 to 75 years, inclusive. 3. signed informed consent form. 4. one of the following diagnoses as per international classification of diseases -10: 4.1. k80.1 calculus of gallbladder with other cholecystitis 4.2. k80.2 calculus of gallbladder without cholecystitis 5. indications for planned laparoscopic cholecystectomy. exclusion criteria: 1. recall of informed consent by patient. 2. non-compliance with the rules of participating in the study by patient. 3. getting pregnant. 4. required conversion during surgery. 5. required repeated surgery. 6. development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient. 7. another reasons appeared during the study and interfering conduction of the study as per the protocol.

Keywords: adhesion safety
study of mr-107a-02 for the treatment of acute postoperative pain following herniorrhaphy

Conditions: Acute Pain; Post Operative Pain; Pain

Summary: mr-107a-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.


Eligibility criteria:
main inclusion criteria: 1. requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia. 3. has an american society of anesthesiologists physical status of i, ii, or iii. 4. pain intensity (pi) using nrs-r ≥4 at any given timepoint during the 5 hours following end of surgery in the eligibility assessment as well as in the baseline assessment (nrs-r and nrs-a) immediately pre-dosing. 5. rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following end of surgery. 6. able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions. main exclusion criteria: 1. previously dosed with this formulation of mr 107a 02. 2. had any prior inguinal hernia repair in the past 24 months. 3. has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy). 4. has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the herniorrhaphy, and which may confound the postoperative assessments. 5. known hypersensitivity to aspirin, nsaids, or other medication used in the study. 6. body mass index (bmi) \>40 kg/m2 at screening. 7. body weight of \<43 kg (105.8 lbs) at screening. 8. history of gi bleeding or peptic ulcer disease. 9. known active inflammatory bowel disease, e.g., crohn's disease or ulcerative colitis. 10. a history of bleeding disorders that may affect coagulation. 11. subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.

Keywords: pain
effect of modified dental visual aids on behavior management during dental treatment in children with autism spectrum disorder

Conditions: Child Autism

Summary: there is a need to find an approach that is appropriate for managing children with autism spectrum disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children during the dental appointment.


Eligibility criteria:
inclusion criteria: * patient age between 6-10 years. * child patient has to represent the typical triad symptoms of asd that include: social interaction deficits, communication impairment, language impairment and rigidity of interests. * child patient with asd diagnosis confirmed in the patient's files according to "the dsm-v criteria" (american psychiatric association, 2013). * child patient with mild to moderate asd according to "the childhood autism rating scale (cars)" (schopler et al., 1998). exclusion criteria: * patient age younger than 6 years and older than 10 years. * child patient with other congenital anomalies, for example, "cerebral palsy" or "down syndrome". * child patient with previous dental experience. * child patient with severe asd according to "the childhood autism rating scale (cars)" (schopler et al., 1998).
an observational study of indian breast cancer patients receiving adjuvant therapy with aromasin

Conditions: Breast Neoplasms

Summary: to generate the following data from patients with early breast cancer treated with aromasin® in the adjuvant setting in india. * efficacy of the treatment with aromasin® * safety of the treatment with aromasin®

na the study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. the decision to terminate had been taken on 16th june 2012 and the lslv occured on 14th september, 2012. it should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria:
inclusion criteria: * patients with early breast cancer receiving adjuvant therapy with aromasin® will be eligible. exclusion criteria: * patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included. * patients with a known hypersensitivity to exemestane or its metabolites will also not be included.

Keywords: an observational study of indian breast cancer patients receiving adjuvant therapy with aromasin antineoplastic hormonal drugs aromasin
the effect of tele-nursing application on self-care ability and daily living activities in fracture surgery patients

Conditions: Lower Extremity Fracture

Summary: this study aims to determine the effect of tele-nursing application based on orem's self-care theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients.

the research was conducted to determine the effect of tele-nursing application based on orem's self-care theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients. the research was planned as a randomized controlled experimental type study. 52 patients (intervention 26, control 26) were included in the study sample using the "simple randomization method". in order to collect the data, introductory information form, self-care agency scale, katz activities of daily living scale and lawton brody activities of daily living scale were used. current hospital procedures were applied to patients in the control group without any intervention. patients in the intervention group were monitored with a tele-nursing application based on orem's self-care theory, and training and counseling were provided for 6 weeks after discharge. data; it was collected face to face once before discharge in both groups, and three times by video conference method: 7-10 days, 18-21 days and 40-45 days after discharge. tele-nursing application monitoring form and reminder infographics, prepared based on orem's self-care theory, were used in the follow-up process of patients who had trauma-related lower extremity fracture surgery. chi square, independent samples t test, analysis of variance in repeated measurements and pearson correlation analysis were used to analyze the data. while there was no statistical difference between the groups in the first measurements, in the 2nd, 3rd and 4th measurements, the intervention group's self-care agency, katz activities of daily living and lawton brody instrumental activities of daily living scale scores were found to be statistically significantly higher than the control group (p\<0, 05). in this study, it was concluded that tele-nursing application based on orem self-care theory has a positive effect on self-care agency and daily life activities.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65, * agreeing to participate in the study voluntarily, * able to understand and speak turkish, * at least primary school graduate, * those who have undergone lower extremity fracture surgery, exclusion criteria: * over 65 years of age, * having an uncontrollable medical problem, * having a hip fracture or fragility fracture due to a fall, * having an external fixator, * amputation develops, * people whose speech, hearing and visual disabilities prevent them from participating in telenursing monitoring will not be included in the study.

Keywords: activities of daily living orem's self care theory trauma nursing tele-nursing lower extremity fracture surgery self care agency orthopaedic and trauma nursing